Tuesday, December 26, 2006

While performing a pacemaker implantation today, I asked for DeBakey forceps (seen above) today – forceps named after an iconic figure in cardiothoracic surgery, Dr. Michael E. DeBakey who underwent an operation at the tender age of 97 that he devised to correct a dissecting aortic aneurism. Although the article that appeared yesterday in the New York Times (and again today in the Chicago Tribune) seemed somewhat apologetic regarding the number of resources used, it nonetheless was a reminder of the incredible capabilities of our health care system when it works the way it should. Gratefully for his family, colleagues and friends, Dr. DeBakey made it through the ordeal in what can only be considered a miracle of modern medicine. Certainly the hard work by all of those involved in his care should not go unacknowledged.

But the bigger story beneath this story is a more subliminal and troubling one: just because care can be delivered, should it be delivered to someone at such an advanced age, in such an abysmal condition with such low probability of surviving to discharge? Circumstances in hind-sight would suggest they should. But in the best of circumstances, a healthy 97-year old male in the United States has about a 2.8 to 3.0 year actuarial survival. Now take a ninety-seven year-old with a Stanford Class A, Debakey subclass II, dissecting ascending aortic aneurism which is leaking into the pericardium who is unconcious and near death - well this individual has a much, much lower probability of surviving the surgery, let alone surviving to discharge. And after the surgery, rehabilitating a ninety-seven year-old is an expensive and arduous undertaking. As a doctor practicing in Chicago, I have to ask myself honestly an important question: would I have proceeded along the same course in a patient with a clear “do not resuscitate” order on his chart that demonstrated such a reluctance to proceed with surgery in the first place?

At this time of shrinking resources in health care, physicians are increasingly pressured to ponder such decisions. These decisions are never made lightly. There was a lot of emotion tied to Dr. Debakey’s illness – he mentored many of the colleagues involved in his care. The irony of the affliction was not lost on those caring for him either. They wrestled with the decision to perform surgery, and only when the wife barged into the meeting room, did they decide to proceed.

But Methodist Heart is also a public “non-profit” charitable organization. Money from the institution went to Mr. BeBakey’s care and will likely be itemized under “charitable care” when their income tax Form 990 is filed for 2006. The organization has authority to authorize funds for such care. But with the growing number of uninsured, ever-increasing costs of providing such health and rehabilitative care coupled with the aging of the population, especially the numbers of patients over 90 years of age, who will decide if John Q. Public gets a full court press or more conservative therapy? When such precedents are set, can we continue to turn our cheek to other younger patients with better chances of long-term survival and similarly difficult-to-manage illnesses? Will this level of aggressive care now become the de facto standard of care for all of our patient’s over 90 years of age? Should it? Certainly there were others in Houston with similar concerns.

Hopefully, there not be hard and fast rules guiding us in these circumstances. But while I commend the spectacular care that Dr. DeBakey received, I do so with some trepidation regarding the solvency of our health care system: especially as it pertains to our younger patients in the years ahead.

Why is it that when a holiday comes about, there always seems to be come new strain of virus that decides to take up residence in my respiratory tract and multiply vociferously? I feel like a Petri dish for viral contagion, with my nose running, post-nasal drip, and low-grade fever. And my looks are egregious, as if Santa had tapped me on the shoulder and said, “You’re on for guiding the sleigh tonight.” And while these looks might engender some vote of sympathy by some, I can assure you that my wife, host to a hundred hungry mouths this holiday weekend, thinks otherwise.

But tonight, these problems seem trivial. Tonight, while driving back from my in-laws’ house, I realized that not everyone thinks Christmas is such a great time. For many, this is the toughest of seasons. For me, the realization came from not one thing, really, but a series of stories and events that transpired recently – all part of the human condition – all moving.

For one family, it was the challenge of recalling the loss of their teenage son years before the day after Christmas – dying of a well-known and under-appreciated disease for its lethal potential: asthma. Christmas holds a different meaning to this mother each year. Each year at Christmas, she reflects on her trip to the morgue to identify her son. She recalls the tender words from her father who accompanied her on that trip. He mentioned to her that might that even the horrors of the war he had experienced years before were easier for him to cope with than that trip to the morgue. It seemed to her at the time that this man, her father, was the only one who understood the incredible sense of loss that day. He got it. So this Christmas she will see her father again to re-live his words and support. I hope and pray she finds comfort once again.

For another family, it is the irreversible and irreparable course of cancer that brings their family together tonight to share what will likely be their father’s last Christmas. It was just several days ago that I learned of the daughter’s attempt to remove a portion of the tumor from her father’s face after doctors said there was little that could be done. Afterward, her father asked, “did you get all of it?” To which she had to reply, “No, Dad, I didn’t.” But she tried to do what she could out of love and caring for her father. Who could blame her? Heart-wrenching. But through this, she came to grips with the situation – its inevitability and all – and has gained an amazing amount of emotional fortitude. Tonight she is the one organizing the dinner, she is the one at his side to help her father and mother. Guiding, caring, loving. She will never regret this path she has chosen to help her parents through. I hope this season brings her some comfort during these trying times.

And finally, I learned of a fall of my own father that resulted in a large gash to his face and multiple stitches. It was a simple event – he was just trying to let out his dog early this morning – but too weak to open the sliding door of his living room adequately, the dog burst into the house through an all-too-small opening, sending my father face-first into a table beside the door. “We didn’t want to bother you,” I was told. And I realized that this battle goes on daily – the challenges of walking, bathing, showering, eating – all have become difficult. Bit by bit, challenge by challenge, life continues. Life is hard. It is what it is. But many, many people do not have the privilege to get old and see their children, to share a meal, a song, another Christmas together. I look forward to seeing him this Christmas, too, stitches and all.

So for all of the others out there with similar difficult and trying times this holiday season, take heart. You are not alone. Many, many others are making it through, bit by bit, hour by hour, day by day. I hope that the peace of God be with each of you this holiday season. Enjoy where you can, and where it’s tough, reflect, and savor it all – for it is all in God’s grand plan.

“… And so, I offer you this simple phrase,To kids, from one to ninety-two,Although it’s been said, many times, many ways,Merry Christmas to you.”

Thursday, December 21, 2006

As food bans spread rapidly across the country in the interest of public health, one is left wondering how they will be monitored. With the multiplicity of difficult public health issues before us, it seems that governments nationwide have found a new way to deflect more pressing issues by implementing food bans – and there is a willing cadre of starry-eyed idealists standing by to assist. The dawn of the Food Narcs is upon us.

Some of you might not be aware that Chicago has banned foie gras from our local eating establishments by an ordinance passed by the ever-public-minded Chicago City Council. Since this is difficult to enforce, the overstretched city is relying upon – guess who: concerned citizens. And, indeed, nine restaurants have been warned because people dining at adjoining tables, in their psychologic delicacy, have filed complaints with the city. These offending restaurants, “believed” to have served fois gras, according to the Chicago Tribune, were sent warning letters from the Chicago Department of Public Health after receiving a citizen complaint. A visit by the Department of Public Health occurs after a second citizen complaint, and visits that turn up evidence of the banished dish can result in fines of $250-$500.

While multiple large companies have moved to ban trans fats from their recipes, will other smaller companies risk litigation by not following suit? Certainly the Big Boys will be under careful scrutiny by the legal community because they have deep pockets. But what of the little guy? Who will be overseeing the corner hotdog stand to assure they’re serving trans fat free bagels? Now we know who: fellow community-minded citizens. Isn’t it reassuring to know that if you cannot control yourself, or are victimized by making politically incorrect choices, others will be there to save you from your own behavior?

If people cannot be responsible for behaving correctly, then perhaps the only alternative is for other citizens to monitor them. Maybe they can be sent to food reconditioning camps – Chairman Mao anyone?

Wednesday, December 20, 2006

Here's wishing you a very Merry Christmas and Happy Hannukah. May the spirit of Christmas remain in your heart as your profits soar.

Your guiding principles remain a true wonder in this season of frugality in health care. Your incredible ability to forecast another stellar year of profits (14%) amid growing health care costs to employers and patients is stunning. We, your shareholders, are breathing a big sigh of relief, especially amid all of the current buzz regarding the ethical practices (*cough*) that have been transpired with all of the options backdating and accounting oversights this year.

UnitedHealth forecast 2007 net income in a range of $4.7 billion to $4.75 billion on revenue of about $79.5 billion. The company also backed its 2006 profit target, pegged in a range of $4.14 billion to $4.16 billion. These forecasts, UnitedHealth said, are based on expectations for "gains from increasing market share and strong operating margins" across its business units. In addition, the company targeted operating cash flow at about $6 billion to $6.2 billion next year.

We know that doctors really appreciate your "margins" of health care coverage each time their patients open their "Explanation of Benefits" letters and have to pay progressively larger portions of their health care bill on top of their premiums to feed our beast. Thank you.

As the challenges to health care grow, we are thrilled to offer you wishes for a "very prosperous New Year" next year (*cough *). Now that Medicare has agreed to have doctors kick in 1.5% of their earnings to provide best practices data for you to reap higher profits, you should be perfectly situated to have an even better year in 2008. Keep up the good work.

Monday, December 18, 2006

Michael Mepham who wrote most of the crossword, word scrambles, sudokus for the past 25 yrs... died of sudden death last week in England. Gamers everywhere are mourning his death. More details can be found on his sudoku forum here.

It seems that Time Magazine has decided you (and everyone who accesses or provides content for the Internet) are, indeed, their Man of the Year.

“For seizing the reins of the global media, for founding and framing the new digital democracy, for working for nothing and beating the pros at their own game, Time's Person of the Year for 2006 is you,'' staff writer Lev Grossman wrote in the cover story.

Perhaps the blogging community is receiving this award from Time Magazine with measured tone because of something we bloggers already know. Just as the Internet has equalized the playing field in the media, we might consider a different hero next year.

I would suggest that the Luddites, those contemporary opponents of technological change, take the prize next year. Like Thoreau, they are the ones who keep things in perspective. After all, they are the ones who serve as a balance to the fulcrum of a world going chaotic. The electronic leash has its own downside: the seeming urgency of dispatches from the Blackberry, the hours spent in virtual community rather than family. We might just find that the technophobes hold the balance for a world that thinks it is more substantive than it really is.

Sunday, December 17, 2006

Thanks(?) to Rob over at Musings of a Distractible Mind for his tag regarding this Christmas meme which has been circulating a while... It's fun to play along...

1. Hot Chocolate or Egg Nog?Well, the nod goes to the Nog, at least in limited amounts – it reminds me of the season. And I have this thing about dying from something I understand…

2. Does Santa wrap presents or just sit them under the tree?Huh? Wrapped, of course! Special ‘North Pole’ wrap.

3. Colored lights on tree/house or white?Honestly, I had always done white on the house, but his year I noticed just too many houses that way, and went to the multi-colored variety and love it! I climbed thirty feet up a ladder in a death-defying exhibition of idiocy that provided wonderful entertainment for the neighbors – I noticed them watching me like they were waiting for the big car crash at a NASCAR race… but I survived. (Maybe next year I’ll hire someone to do this…) The tree has been and always will be multi-colored.

4. Do you hang mistletoe?No. I’m over that. I mean, when you have a Cadillac in the garage, why go after a Ford?

5. When do you put your decorations up?We never put them up before 1 December. Thanksgiving is important in our house.

6. What is your favorite holiday dish?I make a mean Buche de Noel.

7. Favorite Holiday memory?Santa always had a unique way to expose the last present. A small card on the tree attached to an ornament would have a limerick to take you to the next limerick, then the next limerick, then another, until 5 or 6 poems later, the final resting place of the present would be exposed. Or other times there would be a long string attached that would wind around the entire house! The anticipation was incredible!

8. When and how did you learn the truth about Santa?What truth? Santa still comes every year, one way or another…

9. Do you open a gift on Christmas Eve?Only one is permitted, after we attend church.

10. How do you decorate your Christmas Tree?Carefully, except for this year when we experienced Christmas Tree Syncope.

11. Snow! Love it or Dread it?Love it! I mean, what’s better than a White Christmas?

12. Can you ice skate?Sure, but my ankles usually pay a price.

13. Do you remember your favorite gift?I remembered it every year, until the next year, when another magic gift arrived.

14. What’s the most important thing?Family and our faith in God.

15. What is your favorite Holiday Dessert?See number 6.

16. What is your favorite holiday tradition?Each Christmas Eve, luminary are lit in our neighborhood up and down blocks and blocks just after dusk. The drive to church sends chills down your spine.

17. What tops your tree?An angel that my daughter places there after she climbs on my shoulders.

18. Which do you prefer giving or receiving?My mother always said, and I agree, “The gift of giving is with the giver.”

19. What is your favorite Christmas Song?Oh Holy Night.

20. Candy canes, Yuck or Yum?Yum, baby, yum. I can only do one small one a day at most, though.

Saturday, December 16, 2006

A recommendation by European metabolic researchers to place obesity helpline numbers on clothes for fat people appeared yesterday and caught my attention in part due to the concerns of obesity in England, but mainly due the discriminatory nature of the labels. To me, it is yet another example of government and academics overreaching into the private lives of our patients. Unfortunately, with the world-wide distribution of these stories, it is frightening to think that other government officials might think this is a good idea. With this logic, why stop with labels for the obese? Why not place labels appear on the flies of trousers or the thongs sold at Victoria's Secret that say, "Promiscuity is a high risk behavior and could kill you." Or why not put a warning label inside baseball jerseys that says "Excessive beer consumption can be hazardous to your health?" And staying completely mundane, when was the last time you read your pant or shirt label anyway?

Will such labels change eating behaviors? Doubtful.

I have never met an obese individual who didn't know they were obese. Many of them have very real reasons they are obese, including psychosocial issues that are far more resistant to intervention that any warning label will correct. Some of these people are unhappy, others are indifferent, others eat for nurturance, for others it is a compulsion. Others are just exasperated at their inability to gain control over their situation. Whatever the root cause, the psychodynamics of obesity are too complicated to be solved with garment labels. Do we really think government intervention with "labels" will solve these deep seated and very personal issues? On the contrary, these labels might reinforce the very negative perceptions they intend to help, catalyzing the compulsion still further.

Personal responsibility and real medical and social interventions are needed to battle the obesity epidemic. Socioeconomic stressors also play a significant role. Only improved awareness, education, increased physical education and support programs paired with regular physician follow-up will help guide people to lifestyle modifications that will insure a safe, long-term solution to this problem. There is no quick fix.

Significant challenges lie ahead for governments and healthcare providers dealing with the obese. For starters, few individuals see mild or even moderate obesity as a health issue - after all, most of us chubby soles feel fine. We (doctors and educators) have done a poor job educating the population regarding what's good and what's bad: mixed messages abound. We make deamons of trans fats, saturated fats, high-sugar content foods, creams, Oreo cookies, and on, and on, and on, while placing soda machines in our schools and feeding high carbohydrate junk at lunchtime in schools. Exercise, although touted, is seldom granted time to perform in workplaces fixated on productivity. The relentless buzz regarding low-carbohydrate diets, sugar-free diets, and others becomes background noise: blah, blah, blah. They've heard it all, and nothing works for them.

But there are success stories. Some people really do lose weight. Some really do lose their diabetes, hypertension, and chronically painful joints. But most of these successes are due to active intervention by family members, caregivers, and a healthy dose of self-realization of one's situation. Pants labels just aren't in the mix here. Only when each of us takes responsibility, doctors and patients alike, will there be success in this war on fat.

Wednesday, December 13, 2006

Yesterday’s JAMA article, co-authored by Drs. Rachael Werner and Eric Bradlow, compared the World’s Best Hospitals (top “75th percentile”) to Johnny Q Public hospital (bottom 25th) and found that, gee, people die at about the same rate at hospitals in the US. Amazing. But what was beautiful about this study, was the data mining of the data came from The Centers for Medicare and Medicaid Services (CMS)’s own Hospital Compare website. Hospital performance measures that were supposed to ferret out the good boys from the bad boys were found to be crummy measures and only predicted small differences in hospital risk-adjusted mortality rates.

But to the quality nerds that want to use such statistics to form pay incentives for physicians and hospitals, this presents a dilemma. What do you do when everyone does a good job? Or, as the quality nerds would like to say, what do you do everyone in the United States is performing in the same mediocre fashion?

… Michael Rapp, director of CMS's quality measurement and health assessment group, said the researchers most likely would have found bigger differences between hospitals if they'd examined all 22 quality measures used on Hospital Compare. Finding only slight differences when using a few measures is not surprising, Rapp said.

Whoa there, Mr. Rapp. If I have a heart condition and want to find out about the World’s Best Hospital caring for heart disease, why do I need 21 or more other measures? But I know how you will clarify it for me:

Still, Rapp said he agrees that more quality measures are needed to evaluate hospitals. "CMS is actively working to expand quality measures used on Hospital Compare," Rapp said.

Please, Mr. Rapp, give me more data do I can be even more confused. Give our patients more measure to make this “clear.” If the public can’t figure out Medicare Part D, how the heck are they going to decipher the 22 measures you already have, or 100, 200, or even 1000 measures? Is this how we're going to give “power to the people?”

While carefully-controlled drug trials have demonstrated the effectiveness of aspirin or a beta-blocker therapies at reducing mortality after a heart attack, to suggest that measuring compliance with a medical regimen will translate to improved patient mortality outcomes after heart attack in the uncontrolled real world is a leap. Patients are not homogenously selected like they are for such trials. Every patient is unique and every patient’s problem list different. Medicine is complicated, not cookbook.

When a good researcher stops and wonders why his experiment failed, he gains valuable information to steer him in the right direction to test his next hypothesis. CMS does not seem capable of this. Rather, their answer is to develop still more convoluted “measures” rather than focusing on other, more urgent matters that might save the health care system.

I would suggest that CMS cut costs by focusing stricter guidelines for insurers dealing with Medicare patients by restricting overpaid insurance CEO’s and board members and require liability reform nationwide for any state desiring Medicare or Medicaid funds, rather than leaving the insurance, regulatory and legal interests to cripple our health care system further and price our patients out of the health care market.

You see, measuring performance measures by its very nature has a more sinister side, especially if one gets the evaluation measure wrong. Tacitly stated, measuring “performance” differentials implies one must also measure ”non-performance.” And you might as well call it “incompetence.” Doctors, hospital administrators, and people in general don’t like being called, or even considered, incompetent - especially by a governmental body that demonstrates its own inability to get the measure(s) right.

Tuesday, December 12, 2006

This time of year can be a frustrating one for doctors and their families. Oh, heck, it can be frustrating for just about anyone, I guess. But I have found an unusual incidence of problems with decorating my house this year. It’s like negative Karma, a decidedly un-Christian experience, has descended upon our household.

Why, for instance, does the garland I draped with little white lights and saved carefully in an airtight container from last year, decide to have only one half of the lights on the garland strand light? Why is that? And have you ever tried to fix one of those “half strands” of extinguished lights? You go over and grab one of the extra little bulbs attached to the string of lights and find the one bulb that isn’t stained with red (those red ones make that God-forsaken blinking). Now, you try to play hide-n-go seek with 75 other bulbs on the strand to find the one that is out in hopes of resuscitating the strand. It ain’t gonna happen. Trust me, I’ve tried. So why do they include those stupid little bulbs, anyway?

My wife suggested the miniscule fuse also attached to the end of another string of lights might fix another strand. Have you ever tried to place the fuse inside the plug? Usually you need a set of forceps and a loop microscope to identify the old fuse and extract it. Damn thing looks like one of the inner ear bones, but I digress. Anyway, you put that fuse in the plug and well, it still doesn’t work. Don’t ask me why. Finally, after saying enough expletives to fill a dictionary, I gave up. I went to Walgreens tonight to just buy some new strands.

And of course, Walgreens is all out of the little white lights. Oh, I could have all red, all blue, all green, or all multicolored, but the little white ones? They’re all out. They’re hanging on everyone else’s trees and bushes.

But three other stops later at other stores, I found a few short white strands, brought them home, and plugged them in and all fared well. One problem conquered.

But another was about to develop.

Last weekend I was on call. I hate call. But it’s a necessary evil.

But my wife hates my call weekend worse than I do, especially this time of year. There’s so much to accomplish that the last thing she needs is her husband off “saving lives” while she saves the family. This weekend was especially difficult, so she decided to act unilaterally and get the Christmas tree without me. She thought she would surprise me.

So when I came home later that evening, there is was, leaning a bit, but adorned with all of the beautiful multicolored lights and special garland. She and my daughter were so proud. They had managed to place it in an old tree stand next to our front window. Very festive, indeed, and a wonderful gift for me to see it up without having to wrestle with that sucker this year! Wonderful!

So the whole family decorated the tree with our heirloom ornaments and remembrances. It was all such a Norman Rockwell painting. Christmas music rang through the air, it was cool outside, the fire was going in the fireplace, and you could here the family decompressing:

Oh the weather outside is frightfulBut the fire is so delightfulAnd since we've no place to goLet It Snow! Let It Snow! Let It Snow!

After we had finished, we each went to our ways, and I decided to sit and check my e-mail. Little did I know our tree had fallen ill.

There was no warning. No time to react. Yep. Fallen ill. It couldn’t, wouldn’t, shouldn’t be, but was: Christmas tree syncope right there in our living room. The entire behemoth came crashing down, with 30-40 ornaments smashed to smithereens. Countless others rolling across the floor. Sadly, my son’s special ornament pulverized into little red and silver shards.

My wife and I looked at each other. No words were spoken, but the tacit message I could hear was, “If you say one word after I put up with all this crap today, you better not say a (*$%)( thing.” An hour later we found ourselves positioned, smily-faced at yet another Christmas cocktail party.

Ho, ho, ho.

Well, I’m off to pen one of those rosy, Pollyanna, “My Family is so Perfect,” Christmas letters…

Boy, I'm not sure I agree with the new recommendations put forth today by the American Heart Association regarding more manual compressions before delivering a defibrillation during Cardiopulmonary Resuscitation (CPR):

The old guidelines called for repeated shocks along with a pulse check before administering CPR. The new way endorses a single shock followed by two minutes of CPR, the Heart Association said.

In the EP lab where we witness cardiac arrest and all of its excitement first-hand, there is NO QUESTION that early defibrillation works. I have had times where one shock is not enough to resuscitate a patient in our lab setting. If I stopped to first perform CPR before shocking one of my patients during witnessed cardiac arrest, I am sure we would have a higher complication rate in our laboratory. Many of our patients have ischemic coronary disease, and when the heart fibrillates, no effective blood flow is pumped from the heart, cuasing it to be more susceptible to ventricular fibrillation, not less.

I suppose in patients who have collapsed for a while, there might be logic in the AHA's recommendations - circulate a bit of oxygenated blood to the heart first, then try shocking. But certainly in witnessed cardiac arrest, I'm going to shock them more than once every time.

... it was six months and over 400 posts ago that we last hosted Grand Rounds. It's surprising how much has changed in that time, but also how much has stayed the same. We had a number of submissions from bloggers we featured last time around, along with a number of new faces. It seemed too that the quality of blogging has only continued to rise. Maybe it's simply a factor of writers becoming more comfortable with the medium. Or maybe it's a function of medical bloggers pushing each other to excel. Whatever it is, one thing is for sure: we the readers are the ones who truly benefit.

Monday, December 11, 2006

And just when the cardiovascular surgeons thought they might wrestle back the coronary revascularization business, a new completely bioabsorbable coronary stent released its first early clinical results today. This stent is produced by Bioabsorbable Vascular Solutions, Inc. (BVS), a Guidant (now Boston Scientific spun off to Abbott Vascular during the earlier Guidant acquisition by Boston Scientific):

The new BVS stent is made of a polymer that dissolves into lactic acid over two to three years. Lactic acid is a naturally occurring substance in the body, produced after exercise. It breaks down into carbon dioxide and water, and is absorbed by the body.

Unlike earlier bioabsorbable coatings over a bare metal stent, like the earlier Biomatrix stent, no bare metal exists in this stent. Of note, the stent also contains everolimus, and elutes this drug over an estimated 120 days. These patients are part of the ABSORB clinical trial enrolling up to 60 patients in Belgium, Australia, Denmark, France, the Netherlands, New Zealand, and Poland. While the initial results seem promising, there are a few caveats worth mentioning:

These stents have no long-term track record and have not yet begun trials in the US, to my knowledge, but the international experience will form a basis to begin the first US trials, if successful.

The stents will have an initial inflammatory reaction after implantation since the polymer is a foreign body. As such it is still subject to restenosis, though the everolimus should help reduce this inflammatory response.

It should have better imaging in MRI scans and CT scans since the polymer will not cause the reflectance artifact like metal stents.

While the absorbable nature of the stent is intriguing, the mechanism of late-stent thrombosis is unknown, so long-term studies on anti-platelet agents will still be needed, especially since the stent is drug-eluting for only 120 days of its 2-3 year existence in the coronary artery. It's just too early to claim that these new stents will reduce in-stent late thrombosis risk yet.

Nonetheless, it is refreshing to see some new news on the coronary stent front that might make the debate between bare- and drug-eluting metal stents a mute one.

Sunday, December 10, 2006

At the last minute, like the Grinch Who Stole Christmas and later repented, Congress's proposed 5% Medicare payment cuts were spared, in part due to a strong push by physician advocacy groups. To be reported in tomorrow's Wall Street Journal (subscription):

Congress agreed to erase a scheduled reduction in payments to physicians, but it made a 1.5% bonus payment available only to physicians who report to Medicare how they perform on certain specified barometers of health-care quality. Initially, the payments will be based on whether the physician reports the data, but the system lays the groundwork for higher payments to better-performing physicians.

Among the information Medicare officials will collect: whether doctors provide aspirin and beta blockers to patients having heart attacks, and whether elderly patients are screened for their risk of falls. These practices are considered indicators of good patient care.

Hospitals, too, will have greater responsibility for reporting quality-of-care data. While most hospitals already have been doing quality reporting on inpatient care, the new legislation requires them to do so for outpatient services to receive the full payment scheduled under law for those services. Congress added an additional wrinkle to the program in the latest legislation, requiring the Department of Health and Human Services to consider ways that the hospital data could be made available to the public.

The implication of this bribery for reporting is significant, since it establishes a measly 1.5% premium on "Pay for Performance" - hardly a robust incentive. For instance, for a 20-minute outpatient follow-up visit that averages a $54 dollar Medicare reimbursement, Medicare is willing to pay an additional $0.81 for us to submit data about the drugs we give the patient. Since the payment isn't enough to offset the cost in man-hours to supply the data, will the data be complete or accurate?

And I hope they realize that not ALL patients with heart disease can take aspirin (due to allergies) or beta blockers (like patients with severe lung disease) after a heart attack. Will we be paid to "perform" when we fail to treat patients with these drugs in such circumstances?

"Fat may well be the next tobacco, and trans fat is likely to be one of the most promising targets, because it's so dangerous and totally unnecessary, and because there are so many legal theories under which it can attacked," says law professor John Banzhaf who helped lead the movement to sue cigarette manufacturers, and started the anti-obesity litigation movement.

For lawyers it seems, it's not about health, it's about the money: over $24.5 million and counting ... look for more of them to join the feeding frenzy.

Friday, December 08, 2006

The FDA's drug-eluting stent safety panel recommended today that the labels of Cypher (sirolimus-eluting) and Taxus (paclitaxel-eluting) stents be changed to include a warning that off-label use of the devices may carry an increased risk of stent thrombosis, myocardial infarction, and death. The panel also called for the label to carry a recommendation for 12-months of dual antiplatelet therapy with aspirin and Plavix (clopidogrel) when drug-eluting stents are used off-label.

This is a reasonable recommendation based on the paucity of data that exists to date. Look for new package inserts and for cardiologists contining their current treatments. Once formal recommendations are issued, some big trials like the SYNTAX trial, which compares stent therapy to cardiac bypass surgery for three-vessel and left main coronary disease, might need to change their consent forms and duration of clopidogrel (Plavix) therapy in the stent-treated arm.

For patients with drug-eluting stents, be sure to check with your doctor if additional Plavix and aspirin therapy are warranted in your case. Here is the FDA's "on-label" use for Boston Scientific's TAXUS stent (pdf file):

The TAXUS Express 2 Paclitaxel-Etuting Coronary Stent System is indicated for improving luminal diameter for the treatment of de novo lesions < 28mm in length in native coronary arteries > 2.5 to < 3.75 mm in diameter.

The CYPHER® Stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length < 30 mm in native coronary arteries with a reference vessel diameter of > 2.5 to < 3.5 mm.

Your doctor can help you sort this out and most patients will be just fine, but some may need slightly longer anti-platelet therapy with aspirin and clopidogrel (Plavix).

The big expensive panel convened to decipher the risks of drug-eluting versus bare metal stents, has so far done little to clarify issues regarding management of patients with drug eluting stents for cardiologists. So far, the meeting seems more like a PR meeting to reassure the public that industry-sponsored experts are confident in the safety of stents.

Cardiologists already know this. In days of old before drug-eluting stents, cardiothoracic surgeons were still pretty busy helping to manage patients who would return with re-narrowing (re-stenosis) of their bare metal stents after cardiologists could do little to intervene. But now, cardiothoracic surgeons are busy finding other things to do, like atrial fibrillation ablations, since multi-vessel angioplasty and stenting has become commonplace due to the effectiveness of drug-eluting stents. Cardiologists have pushed the indications beyond treatment of simple vessel narrowings, tackling branch-vessel narrowings that are much more complicated. In fact, the FDA estimates that 60% of these devices are used outside manufacturers’ labeling.

What cardiologists want to know (and other doctors who manage these patients) are management issues: in what situations should a patient NOT receive a drug-eluting stent? Should these stents be used in off-label complicated branch-vessels in an off-label, side-by-side fashion known to be higher risk for clotting? How long do patients need clopidogrel (Plavix)? What do we do with patients who require surgery and have drug-eluting stents to minimize their risk of in-stent thrombosis?

Instead we were treated yesterday to a feel-good session on the safely of stents by cardiologists who receive (either personally or for their institution) significant funds from the stent manufacturers.

While it is good to allay the concerns of the millions of people out there with drug-eluting stents, I hope we get to hear more “meat” today about management and follow-up of our patients, or at least, about plans to organize prospective trials to address some of these questions.

BlueCompare is a program developed by Blue Cross and Blue Shield of Texas to enable more informed health care decisions by consumers.

Oh, but don't worry:

This information is provided to assist you in selecting a health care provider. It is not intended to be a recommendation. (emphasis mine - wait, are you "assisting" or "recommending?") Your selection is a personal choice, and you should not base your decision solely on Affordability or Evidence Based Medicine (EBM) Indicators.

Not a recommendation? Oh, pleeeeze! What else do you call it? A suggestion?

Worst of all Blue Cross offers no mechanism to determine if their "EBM's" are accurate, nor are they verifiable. Where do these data come from? Most insurer personnel I know don't have a CLUE about medicine. Yesterday, I spent over an hour on the phone trying to get a test paid for by XYZ insurer because the screening personnel didn't know the difference between a vein and an artery. Bozos all.

And how often will these "website doctor thingamabobs" be updated? If I were a doctor in Texas (and no doubt this trend will spread), I would want to know the methodology and update frequency of this site. We doctors recognize that these indicators/suggestions/recommendations have NOTHING to do with the care provided by doctors (although they sure imply it), rather they only measure the documentation of the care provided.

But why should anyone care?

Because to not understand methodologies and verifiabity of this data subjects Blue Cross to potential charges of slander against doctors in whom data are misrepresented. And even worse, when a patient with chest pain goes across town in Houston to see a "more affordable" doctor and dies en route due to delayed therapy, there might just be hell to pay.

It’s been a busy period here, so the blogging has been a bit sparce recently, sorry.

I have been thinking about Christmas gifts for our staff this year. They’re the ones who spend countless hours getting charts ready and arranging the little logistics that make such a difference to the overall patient experience. I feel it’s important to acknowledge all of their efforts over the past year. But then I saw how Chicago’s Mayor Daley does his gift-giving a holiday time:

A memorandum sent out last month on city stationery asks department heads and senior staffers to give a "$35 voluntary donation (no checks please)" toward a gift for Mayor Richard Daley and his wife, Maggie.

Seems that’s how things get done here in Chicago.

The article goes on to say that past years they have bought a salt water aquarium and a piece of art from China for him. This year’s gift will reportedly be different.

When the Tribune asked what the present would be, mayoral spokeswoman Jodi Kawada revealed Wednesday that a $2300 charitable donation will be made in the Daley’s names. The money will go to After School Matters, a program overseen by Maggie Daley that offers activities for city teenagers.

Seems to me the names of all of the contributors should be mentioned, not the Daleys.

"Are we going to start to outlaw what everyone should eat in the city of Chicago? The City Council will be sitting in your kitchen to determine what you should eat on Sunday after church." - Mayor Richard Daley, Chicago

The recently announced and much anticipated ban of trans fats in New York restaurants reminds me of the fois gras ban here in Chicago earlier this year. No one was there to enforce it and it looked like special interests (animal rights activists) got to tie up Chicago legislature with something that meant little to the general population, while ignoring other more pressing public health and safety issues. It was repealed a little over a month after it was signed into law. Will this new trans fat ban spread across the country or will the ban eventually be repealed? Right now, it's tough to know.

Now please understand that I tow the party line: trans fats are bad for you. There, I said it. They raise low density lipoproteins (LDL) and lower high density lipoproteins (HDL or "good cholesterol"). And trans fats are ubiquitous fixtures in our culinary landscape, adding plenty of calories to our diet.

But how many of us really know what fats our foods are cooked in? How many people inquire about this in restaurants? How many know a "good oil" from a "bad oil" in their kitchen? Will it matter to our obesity epidemic? Do you realize those Girl Scout cookies you love each year are cooked in trans fat oils? Will you care when a doe-eyed little girl asks you to purchase her cookies? No, you will purchase them to help her. Will you care if she can't raise funds for her cause selling cookies door to door in New York due to a ban on trans fats? You bet.

But like seat belt requirements in cars, there are occassionally good ideas that come from governmental regulation and legislation. Certainly adding seat belts to cars, and later air bags, has saved countless lives. Perhaps trans fat bannings will lower coronary deaths, but unlike tallying deaths from car accidents, proving cause and effect of heart attacks as they relate to trans fat consumption will be nearly impossible to prove. Will doctors look over the recently deceased in the Emergency Room and say, "Damn, we lost him from a trans fat overdose!" I think not. Dietary intake is just one risk factor for premature coronary deaths.

And most people don't even know the difference between a trans fat and a mono- or polyunsaturated fat. Sorry, they don't. But fat of any kind burns at 9 calories per gram while carbohydrates and protein burn at 4 calories per gram. Eating too many calories (including fat) of any kind means you're still likely to get fat.

But food companies can now pander to the uninformed. Already there are "trans fat free" food labels on your store shelves ... even when food companies still have their foods loaded with TONS of other forms of fats and calories. Another fad is born.

Now I ask you, what has the New York Health Department accomplished, really?

There seems to be a lot of gnashing of teeth about what to recommend for people who have received drug-eluting stents. Should patients continue the anti-platelet (and hence, anti-clotting) drugs, aspirin and clopidogrel (Plavix) indefinitely? Or should these drugs be stopped sometime after one year?

A big, manufacturer-friendly, FDA “advisory panel” will convene on Thursday and Friday in Gaithersburg, Maryland to discuss this topic and review meta-analyses, anecdotal-isms and retrospective registries. No one will have any prospective, randomized data over many years comparing the risk of clot-formation in stents compared to the risk of bleeding from Plavix and aspirin.

It is important to remember that restenosis of bare metal (non- drug-eluting) stents due to the growth of scar-like tissue (called "neointimal hyperplasia") inside the bare stent was a real problem in patients before drug-eluting stents hit the market. Smaller diameter stents were most likely to develop this complication compared to larger diameter stents. But after drug-eluting stents burst into the market, this problem became much less prevalent. Cardiologists stopped seeing the "frequent fliers" for repeat stenting and no longer performed the more complicated brachytherapy (radiation) to prevent restenosis. Cardiologists aren't stupid: they liked this feature of drug eluting stents.

Unfortunately, over the course of time, it was eventually discovered that drug-eluting stents occassionally clot shortly after the Plavix medication was discontinued. This didn't happen all the time, mind you. It happened about 5 percent of the time. But unlike restenosis of bare metal stents that occurs slowly, the clotting seen after stopping Plavix in a drug-eluting stent is often an abrupt, sudden event leading to much larger heart muscle damage.

It became clear that taken together, Plavix and aspirin are important deterrents to the formation of blood clots in stents. But the long-term risks of life-long Plavix, especially it’s risk for developing later bleeding complications, are unknown. And Plavix is expensive. Many cannot afford the drug and Medicare doesn’t cover the drug unless individuals carry a supplemental drug benefit.

The problem now, in my view, is that there are lots and lots of drug-eluting stents in patients already out there. Stents, once deployed, can’t be removed. And we cannot abandon our patients. So the clot-preventing drugs aspirin and Plavix must be continued for at least a year, or better yet, indefinitely unless the risks of bleeding are excessive.

Also, it would not be surprising if the FDA recommended that larger-diameter stents be bare metal, since restenosis risk is lower in these larger-diameter stents. And look for the advisory panel, in the interest of "safety" to require new stents (and new competitors to the panel's companies they represent) to have to submit "more data," delaying approval of the other companies' stents.

Finally, I would not be surprised if the FDA recommends that a registry be developed to track complications (the FDA loves registries: just look at the recent defibrillator recall fiasco). This might permit a later development of data-based guidelines based on probabilities. One such decision support tool that uses retrospective data has recently been deployed in Kansas.

For the non-cardiologist, issues on how to handle non-cardiovascular surgery in patients on Plavix and aspirin still need to be better defined, but I doubt the panel can cover all of this territory in the short two days ahead.

For now, though, a lot of this will be “flying without instruments.” And the weather is still partly cloudy…

Monday, December 04, 2006

My wife just published a podcast for our Medtees website which makes these goofy medical t-shirts that support lots of charities. You can link to the podcast, produced by PRWeb, on this page and see the shirt that I brought her after her thyroidectomy (such a nice husband, huh?).

Or, if you haven't checked out our ABC 7 News (Chicago) spot filmed earlier, you can view it here and listen to the stories from a few of our customers. (Yes, yours truly is in it, too).

Seriously, there are plenty of good causes that these shirts support, including the American Cancer Society, American Lung Association, Heart Rhythm Foundation, Juvenile Diabetes Research Foundation, the American Academy of Orthotics and Prosthetics Project Quantum Leap (for amputees), the Epilepsy Foundation, Crohn's and Colitis Foundation, CHADD (Children and Adults with Attention-Deficit/Hyperactivity Disorder), American Organ Transplantation Association, Arthritis Foundation, etc., etc. We're happy to say that over $1000 has been donated to these charities so far! JDRF has the highest donations, followed closely by the Heart Rhythm Foundation and American Cancer Society in a close race for second place.

International customers have included folks from Canada (eh?), the United Kingdom (the other side of the pond), Australia (Down Under), New Zealand (WAY Down Under), Puerto Rico (Que pasa?), Greece, Finland, the Netherlands, and Argentina so far. International shipping is pretty reasonable: about $7 US.

And yes, we're still soliciting ideas for new shirts. We do ask that the ideas be "kid friendly" (we like to keep our site at least PG-rated) since kids get diseases, too. But if your idea is used, we'll send you the shirt free. You can e-mail me your idea(s) at wes [at] medtees [dot] com. All contributors are acknowledged and get to decide where to direct the funds for their shirt (sorry, only legitimate 501-3c charitable organizations permitted).

So if you know someone that is sick, isolated, or frustrated with their condition, or someone who loves to poke fun at their condition to advocate for their disease, consider one of these shirts. Get them for you, your friends, or your neighbors and help support your favorite charity this holiday season.

Bloggers learn to love and hate the media. On one hand they help disseminate information, but when it is done poorly, misinformation can be worse than the news they intend to spread. Such is the case when headlines read like 'Fridge Magents "Can be a killer."'

So what are they talking about? First of all, Johnny Everyman is not likely to be struck down by refrigerator magnets. What clever Swiss researchers (published in the December issue of Heart Rhythm) did is note that when the more powerful, readily-available magnets made from neodynium-iron-boron (NdFeB) magnets of sufficient size (0.8-1.0 cm) are placed within three centimeters of a pacemaker or defibrillator, it can effect a special magnetic switch inherent to all of these devices. Since some jewelry is being manufactured with these strong magnets (and I am aware of newer magnetic name tags that might be placed near the device), then the pacemaker or defibrillator might be affected.

So what happens?

Pacemakers and defibrillators contain a small "reed switch" that is sensitive to magnetic fields that allows patients and their doctors an opportunity to affect their device to perform specific functions outlined below.

In the case of pacemakers, the activated reed switch tells the pacemaker to pace, irrespective of the person's underlying rhythm, at a specific rate (determined by the manufacturer of the pacemaker). When the rate changes, this tells doctors how much voltage is left in the person's pacemaker, and uses the paced rate to act like a battery meter, telling doctors when the pacemaker battery voltage is getting low. It does NOT inhibit pacemaker output. (Oh, there will be some wise guy that says that pacing that does not synchronize with one's heart rhythm could land in the "vulnerable period" of the cardiac cycle and induce an abnormal rhythm (and yes, that can occur), but magnet checks are done tens of thousands of times a day in the US and I have never heard of someone dying from this with conventional pacemakers).

In the case of a defibrillator (that treats abnormally fast and slow heart rhythms), the reed switch acts slightly differently. Again, a magnet over the person's defibrillator does NOT inhibit pacing at all. In the case of a defibrillator, a magnet over the device that is powerful enough to trip its reed switch will suspend detection of rapid heart rhythms while the magnet is over the device. In the case of this article, this will only happen if a magnet is held within three centimeters of the device. That's only 1.5 inches, folks. In other words, one of these fridge magnets or pieces of jewelry would have to be held virtually right over the device to have any effect. Certainly, if the person had the unfortunate luck that a rapid heart rhythm occurs when a magnet of sufficient strength is over the device, then the device would not detect this rapid heart rhythm and it could be fatal. But the odds of that happening are very, very low. Remember, most of us don't attach refrigerator magnets to our chest. And the titanium can that makes up a pacemaker or defibrillator is not magnetic, so even if a person with a defibrillator tried to place a refrigerator magnet on their, it wouldn't stick. Carrying a refrigerator magnet in your hand is much farther than three centimeters from the device. So before you rush to replace all of your refrigerator magnets, take heart, you can still use them and will live to tell about it.

I think this study is interesting and warrants consideration for pacemaker and defibrillator patients, but a healthy dose of reality and awareness needs to temper the lethal hysteria generated by the investigator’s comments and the press’s eagerness to promulgate hysteria in the interest of improving readership.

Sunday, December 03, 2006

Alright, Dr. A started it, and Dr. K tagged me tonight: pick your 5 favorite Christmas songs and get five other fellow-bloggers to do the same. As memes go, this one is easy and a great way to share the season with friends while reflecting on our youth and our own kid's excitement during the holiday season. My favorites:

5. "Grandma Just Got Run Over by a Reindeer" - kind of fits my sick sense of humor.

4. "It Came Upon a Midnight Clear"

3. "What Child is This?"

2. "Joy to the World."

And my alltime favorite, sung while the church lights are dimmed and the flame from a single candle is carried to everyone's else's candles at midnight on Christmas Eve:

Citing patient safety, Pfizer said in a statement that it is terminating all clinical tests of torcetrapib and its plans to bring the drug to market. The company said it is asking doctors participating in studies of torcetrapib to tell patients to stop taking the drug immediately.

The reason was too many deaths in the torcetrapib plus Lipitor (atorvastatin calcium) arm of the trial, compared to Liptor alone.

The company said that 82 patients taking a combination of torcetrapib and Lipitor died, compared with only 51 deaths among those taking Lipitor alone. Pfizer said the study cast no doubt on the safety and effectiveness of Lipitor.

With such a large clinical trial, the excess deaths in the combination treatment arm of this trial could not go unnoticed.

As painful as it must have been, Pfizer did the right thing. They will feel the sting in their stock price over the short term, but in the long term, they saved many more lives with their bold decision and will survive to develop another blockbuster drug another day.

In an unusual move, a federal judge has temporarily barred ousted UnitedHealth Group Inc. Chief Executive William McGuire from exercising stock options or receiving any retirement pay or other exit benefits while an external, board-appointed committee establishes whether the health insurer has claims against him.

The order, which backs a joint motion by attorneys for several shareholder lawsuits and Dr. McGuire himself, puts on hold any agreement between UnitedHealth and its longtime chief executive over the terms of his departure until those legal questions have been answered. Dr. McGuire agreed to resign in October after an internal report concluded millions of stock options were likely backdated on his watch. He left the company yesterday with negotiations over his retirement package still unresolved.

The injunction is unusual in the annals of executive pay. U.S. District Judge James Rosenbaum of Minnesota handed it down late Wednesday partly at the request of attorneys representing a group of shareholder plaintiffs who have filed lawsuits against UnitedHealth. The complaints argue that the option backdating lined the pockets of Dr. McGuire and other top executives at the expense of the company. "If he were able to reap what we see as ill-begotten gains, we'd be asserting a claim without a remedy," said Karl Cambronne, lead attorney for the group.

No so fast, Dr. McGuire. Let's see what the external committee decides. It is also interesting to note:

Dr. McGuire also supported the plaintiffs' push for an injunction, and his attorneys even drafted the proposed court order, according to one person familiar with the situation said. The departing CEO believes the special litigation committee will vindicate him once "all the evidence is in," this individual said.

Let's see, according to one set of outside reviewers, some would put the odds of Dr. McGuire having timed all those option dates just right was about 200 million to 1? And we're not even talking about those other set of double-issued options, are we?

About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.